Main Subject - Business

WSJ article "IPO Obstacles Hinder Startups" offers a good coverage of how IPOs are becoming to

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

ugher for small venture-backed companies.

This raises the question, what should CEOs and earl

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

y-stage VCs do, once a company has reached $100 M+ in annual sales? (Below this threshhold, it

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

is absolutely undesirable to go public; investor courting, ongoing investor management, Sarba

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

nes-Oaxley compliance related paperwork and massive expenses - being some key distractors ...)

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

In general, by year 5 or year 6 in a company’s history, the Series A investors, the Founders

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

, and the early executive team that is still around - get itchy to extract some liquidity. Tod

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

ay, given the sophistication, the available money, and the level of activity in the Private Eq

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

uity industry, a late-stage / LBO fund could easily step in and provide the necessary liquidit

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

y.

Liquidity, I believe, is no reason to go public prematurely. An enterprise that has built-

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

in scalability should stay private, stay on course, and execute, execute, execute. If, however

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

, the business does NOT have built-in scalability - and most don’t - they should absolutely NE

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

VER go public. They should get acquired, and become part of a larger portfolio.

Last year, 41

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

start-ups backed by venture-capital investors became publicly traded U.S. companies, down fro

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

m 67 in 2004 and 250 in the boom year of 1999, according to research firm VentureOne.

I would

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

say, the recent numbers are much closer to what they should be.

After all, how many enterpri

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

ses really have built-in scalability in their business model?

Most companies simply go public

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

and then struggle, giving smart investors absolutely no reason to touch them, and hence, givi

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

ng analysts no incentive to cover them!

Rather, a secondary exit market for private placement

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

s of a chunk of the company’s shares held by early shareholders - is a far better alternative.

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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You've probably evaluated a wide variety of ways different people and companies promise you 'ways to make money' either on or off the Internet. Here’s my experience with one of them.

Imagine a river. Then visualize all that the river carries with it. Apart from the water and fish, there are other elements which form the river. Processes are very much like a river. They flow in a natural direction and carry information with them from one point to another. The process of Value Stream Mapping is a by product of the Lean Manufacturing process pioneered by Toyota and the core fundamental is to identify the areas of waste which can be avoided within a manufacturing or office process.

Does your Canadian company need financing? Read this article to learn about invoice factoring and discounting.

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